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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K210358
Device Name Neurescue device
Applicant
Neurescue Aps
Kobmagergade 53, 2
Copenhagen,  DK 1150
Applicant Contact Habib Forest
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact Semih Oktay
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Codes
DQO   DQY  
Date Received02/08/2021
Decision Date 05/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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